MUSTCOOL: Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
Sponsor
Medical University of South Carolina (Other)
Overall Status
Completed
CT.gov ID
NCT02626156
Collaborator
(none)
140
2
2
58
70
1.2
Study Details
Study Description
Brief Summary
The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month randomized clinic trial, skin temperature will be monitored daily, a maintenance dose of cooling gel pack or placebo will be applied three times weekly to the affected skin, and a bolus dose of cooling will be applied for 5 consecutive days if skin temperature becomes elevated. Outcomes on the incidence of leg ulcer recurrence, pain, physical activity and quality of life will be measured.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The goal of this randomized control trial is to test a patient directed self-monitoring and self-management intervention aimed at preventing the recurrence of chronic venous leg and diabetic foot ulcers using skin temperature and cryotherapy (cooling). This MUSTCOOL study is a novel ulcer prevention strategy for patients at highest risk for developing chronic ulcers; those with a previous history. The aims are to compare a cooling treatment to a placebo to determine the outcomes on ulcer recurrence, pain, physical activity and quality of life.
Individuals with newly healed chronic ulcers will be invited to participate in MUSTCOOL's two component intervention:
-
self monitoring skin temperature over targeted "hot spots" daily with an infrared thermometer; and
-
maintenance cooling with a cooling pack (or placebo pack) placed over the "hot spot" three times each week for 30 minutes. If the temperature of the "hot spot" becomes elevated 2°F above baseline (average of 30 days of daily temperature readings) for 2 days in a row, a bolus regimen of 5 consecutive daily, 30 minute applications of the cooling or placebo pack will be implemented. The safety and side effects will be monitored, however, there have been no reported adverse events reported in our previous cryotherapy studies.
This study was designed as a chronic ulcer prevention intervention that targets the remodeling phase, the final repair process of healing after chronic ulcer closure. The skin environment is particularly vulnerable to ulcer recurrence due to a persistent aberrant inflammatory state. The previous research conducted by the study team has demonstrated that cooling this skin reduces the abnormal metabolic activity, protecting it against ulcer recurrence. Recent advancements in infrared technology allow us to take images of the affect skin to identify the area that has the highest temperature or vulnerable "hot spot". These "hot spots" will be self monitored by patients with newly healed ulcers in the home with an infrared thermometer that date and time stamps each reading. The study's outcomes on physical activity will be evaluated with an accelerometer. It is hypothesized that by improving the skin environment and reducing pain, patients will more likely be physically active and have better quality of life, all measurable goals for this study.
This prevention strategy will be evaluated over six months in 180 patients, 90 of whom will be randomized to receive the cooling pack and 90 the placebo. The goal is to test this non-pharmacological, non-invasive clinical intervention as a tailored self-management strategy to prevent chronic ulcer recurrence. It will also determine alleviation of symptoms such as pain, and the debilitating effects on physical activity and quality of life.
Study Design
Study Type:
Interventional
Actual Enrollment
:
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence
Actual Study Start Date
:
Jun 1, 2015
Actual Primary Completion Date
:
Mar 31, 2020
Actual Study Completion Date
:
Mar 31, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cooling gel pack A cooling pack will be applied to affected leg or foot skin where an ulcer has recently healed for 30 minutes three times a week (preventive maintenance). Patients will self monitor skin temperature of affected skin daily to detect elevation and will cool the affected skin daily for 5 consecutive days (bolus) if the skin temperature becomes elevated 2°F above the baseline. |
Device: Cooling gel pack
Individuals will self monitor skin temperature of skin over a recently health venous leg or diabetic foot ulcer with a dermal thermometer. A cooling gel pack will be applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increases and stays elevated 2°F above the usual temperature of that site, the individual will cool the skin 5 consecutive days and will continue to monitor skin temperature.
|
| Active Comparator: Cooling cotton pack A cooling cotton pack will be applied to affected leg or foot skin where an ulcer has recently healed for 30 minutes three times a week (preventive maintenance). Patients will self monitor skin temperature of affected skin daily to detect elevation and will cool the affected skin daily for 5 consecutive days (bolus) if the skin temperature becomes elevated 2°F above the baseline. |
Device: Cooling cotton pack
Individuals will self monitor skin temperature of skin over a recently health venous leg or diabetic foot ulcer with a dermal thermometer. A cotton filled pack will be applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increases and stays elevated 2°F above the usual temperature of that site, the individual will cool the skin 5 consecutive days and will continue to monitor skin temperature.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Ulcer Recurrence [Through study completion at 6 months from baseline]
Number of recurrent ulcers that develop during the 6 month study period for in participants for 4 groups of patients with previously healed venous leg ulcers receiving the cooling gel pack and cooling cotton pack and those with previously healed diabetic foot ulcers receiving the cooling gel pack or cooling cotton pack.
- Change in Pain (Worst Pain, Least Pain, Pain Now) [Through study completion at 6 months from baseline]
Pain was measured with a visual analog scale and reported numerically (0 to 10 with 10 being the most severe pain) at baseline and at 6 months end of study
- Differences in Step Counts [Through study completion at 6 months from baseline]
Differences in step counts reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups.
- Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire [Through study completion at 6 months from baseline]
The Venous Insufficiency Epidemiological and Economic Study-Quality of life/Symptoms (VEINES QOL/Sym) Questionnaire was used to evaluate quality of life. A sum score is provided as an overall quality of life score for both the QOL and Sym portions of the questionnaire. This instrument was used only for the VLU groups because it is a disease-specific measure. Of the 26 items in the questionnaire, 25 items are combined to create a summary score (VEINES-QOL). One item which asks about the time of day the leg problem is most intense, question 2, provides only descriptive information and is not scored. A subset (symptoms score) of ten of these items, questions 1a to 1i and 7, is used to create a symptom score (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym scores, high values indicate better outcomes. VEINES-QOL scores can be compared only to other members of the same sample. Each set of VEINES-QOL scores will have a mean T-score = 50.
- Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory [Through study completion at 6 months from baseline]
The Brief Pain Inventory (BPI) scale is reported as an average score. BPI rapidly assesses the severity of pain and its impact on functioning for intensity and Pain Intensity and Pain Interference. Pain Intensity is measured in four categories: worst, least, on average, and currently, while Pain Interference is measured in 7 categories: mood, work, general activity, walking, relationships, enjoyment of life, and sleep. The patient rates each of these on a scale from 0-10, 10 being excruciating pain intensity and a complete interference in their life. Subscores are determined by averaging over the 4 intensity items for the severity subscore and over the 7 interference items for the interference subscore; possible total scores range from 0 to 10. Higher scores indicate worse intensity and severity.
- Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire [Through study completion at 6 months from baseline]
Change in metabolic equivalent of task (METS) min per week for physical activity per The International Physical Activity Questionnaire reported for 4 groups from baseline to 6 months end of study. Scoring HIGH indicate physical activity levels equate to ~1hour of activity per day or more at least moderate intensity level or engage in vigorous intensity activity on at least 3 days achieving a minimum total physical activity of at least 1500 MET min a week or 7 or more days of any combination of walking, moderate intensity or vigorous intensity activities achieving a minimum total physical activity of at least 3000 MET min a week. MODERATE suggests engagement equivalent to 30 min of at least moderate intensity activity on most days; engage in 3 or more days of vigorous intensity activity and/or walking of at least 30 min per day or 5 or more days of moderate intensity activity and/or walking of at least 30 minutes per day. LOW level means that neither MODERATE or HIGH levels are met.
- Time Spent in Minutes Engaging in Physical Activities [Through study completion at 6 months from baseline]
Mean time spent in minutes engaging in physical activities, reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups.
Secondary Outcome Measures
- Participant Adherence to the Study Protocol [Daily measures starting at baseline for temperature and every other day cooling application during the 6-month study period.]
Using study data logs, appropriate use of the thermometer and cooling pack was measured by the number of participants who adhered to the protocol for taking the temperature of the skin over the healed venous leg or diabetic foot ulcer. Adherence was defined as: the number of participants who were at least 80% adherent to taking their temperatures with the infrared thermometer each morning and the number of participants who were at least 80% adherent to performing the intervention every other day = 3 times times per week during the 6-month study period.
- Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness [Survey conducted at end of the 6-month study period.]
Patients satisfaction was measured by study personnel a during end of study phone survey with the following questions asked as follows (Yes/No): Were study instructions adequate, was thermometer easy to use, found cooling helpful, would cool skin area if it was proven that cooling prevented reulceration; (Easy/Not Easy): completing logs, performing the cooling treatment. Data are for (Yes/No) as number of participants who reported "yes" or if (Easy/Not Easy) the number of participants who reported "easy."
- Knowledge Questionnaire of Study Instructions [Baseline after participant enrollment]
Participants were administered a 12-item (yes/no) questionnaire (test) during instruction at the start of the study, provided by the research personnel to determine comprehension of the protocol and to reinforce study procedures. Score of 12 or 100% was given for all items scoring correctly (1 point per item). Any items for which "no" was answered, remediation was conducted by study personnel at the time the questionnaire was conducted. Means scores are reported per VLU and DFU cooling pack intervention and VLU and DFU cotton cooling pack control.
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Newly healed leg or diabetic foot ulcer within past 7 - 14 days
-
Ankle brachial index 0.8- 1.3mmHg (rule out absence of arterial disease)
-
Willing to wear compression stockings and appropriate footwear
-
Working freezer
Exclusion Criteria:
-
Open leg or foot ulcers
-
Cognitive impairment: unable to recall 2 or more words or draw clock Mini-Cog™ for cognitive impairment
-
Chronic inflammatory or vascular conditions where blood flow of skin may be impaired such as Lupus erythematosus, Raynaud's, scleroderma, end stage renal disease, chronic regional pain syndrome, multiple sclerosis, hypersensitivity to cold, on chemotherapy
-
Unable to preform required protocol activities without assistance (return demonstration to study staff)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of South Carolina | Charleston | South Carolina | United States | 29412 |
| 2 | Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 29303 |
Sponsors and Collaborators
- Medical University of South Carolina
Investigators
- Study Director: Moby Madisetti, MS, Medical University of South Carolina
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT02626156
Other Study ID Numbers:
- Pro00043450
First Posted:
Dec 10, 2015
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Keywords provided by Medical University of South Carolina
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Date recruitment period was January 2017 through December 2019 at wound clinics in the South and North Carolina areas including Charleston SC, Spartanburg SC and Greenville NC via clinicians practicing in those clinics and flyers were distributed in and around community settings such as senior centers, prior to approval from MUSC IRB. |
|---|---|
| Pre-assignment Detail | 246 individuals approached, 211 prescreened eligible, 71 ineligible due to type of wound, could not make regular appointments for study visits, not interested in study, lost contact or developed infection or ulcer changed in size (healed or enlarged indicating deterioration prior to eligibility screening visit); 140 were enrolled - 58 in the DFU group (29 intervention and 29 control)and 82 in VLU group (42 intervention and 40 control) |
| Arm/Group Title | Cooling Gel Pack Diabetic Foot Ulcer | Cooling Cotton Pack Diabetic Foot Ulcer | Cooling Gel Pack Venous Leg Ulcer | Cooling Cotton Pack Venous Leg Ulcer |
|---|---|---|---|---|
| Arm/Group Description | A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg or diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. |
| Period Title: Baseline (Visit 1 to Visit 2) | ||||
| STARTED | 29 | 29 | 42 | 40 |
| COMPLETED | 23 | 22 | 37 | 35 |
| NOT COMPLETED | 6 | 7 | 5 | 5 |
| Period Title: Baseline (Visit 1 to Visit 2) | ||||
| STARTED | 23 | 22 | 37 | 35 |
| COMPLETED | 15 | 17 | 33 | 33 |
| NOT COMPLETED | 8 | 5 | 4 | 2 |
| Period Title: Baseline (Visit 1 to Visit 2) | ||||
| STARTED | 15 | 17 | 33 | 33 |
| COMPLETED | 12 | 15 | 24 | 28 |
| NOT COMPLETED | 3 | 2 | 9 | 5 |
Baseline Characteristics
| Arm/Group Title | Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venous Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cooling Cotton Pack - Diabetic Foot Ulcer | Total |
|---|---|---|---|---|---|
| Arm/Group Description | A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | Total of all reporting groups |
| Overall Participants | 42 | 40 | 29 | 29 | 140 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
64.2
(14.7)
|
64.8
(12.2)
|
57.8
(11.7)
|
61.3
(11.6)
|
62.4
(12.9)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
23
54.8%
|
17
42.5%
|
5
17.2%
|
9
31%
|
54
38.6%
|
| Male |
19
45.2%
|
23
57.5%
|
24
82.8%
|
20
69%
|
86
61.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
3
7.1%
|
0
0%
|
3
10.3%
|
1
3.4%
|
7
5%
|
| Not Hispanic or Latino |
39
92.9%
|
40
100%
|
26
89.7%
|
28
96.6%
|
133
95%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
20
47.6%
|
14
35%
|
8
27.6%
|
5
17.2%
|
47
33.6%
|
| White |
21
50%
|
26
65%
|
20
69%
|
24
82.8%
|
91
65%
|
| More than one race |
1
2.4%
|
0
0%
|
1
3.4%
|
0
0%
|
2
1.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
42
100%
|
40
100%
|
29
100%
|
29
100%
|
140
100%
|
Outcome Measures
| Title | Number of Participants With Ulcer Recurrence |
|---|---|
| Description | Number of recurrent ulcers that develop during the 6 month study period for in participants for 4 groups of patients with previously healed venous leg ulcers receiving the cooling gel pack and cooling cotton pack and those with previously healed diabetic foot ulcers receiving the cooling gel pack or cooling cotton pack. |
| Time Frame | Through study completion at 6 months from baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 140 participants were randomized to either the placebo control group (n=57; 34 VLU, 23 DFU) or the intervention (n=60; 35 VLU, 25 DFU), with a final completion of 117 individuals (84%) |
| Arm/Group Title | Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venous Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cotton Cooling Pack - Diabetic Foot Ulcer |
|---|---|---|---|---|
| Arm/Group Description | A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. |
| Measure Participants | 35 | 34 | 25 | 23 |
| Number [participants] |
6
14.3%
|
3
7.5%
|
11
37.9%
|
5
17.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cooling Gel Pack - Venous Leg Ulcer, Cooling Cotton Pack - Venous Leg Ulcer, Cooling Gel Pack - Diabetic Foot Ulcer, Cotton Cooling Pack - Diabetic Foot Ulcer |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.091 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.02 to 0.3 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | Asymptotic standard error was used | |
| Title | Change in Pain (Worst Pain, Least Pain, Pain Now) |
|---|---|
| Description | Pain was measured with a visual analog scale and reported numerically (0 to 10 with 10 being the most severe pain) at baseline and at 6 months end of study |
| Time Frame | Through study completion at 6 months from baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 140 participants were randomized, with a final completion for this outcome of 83 individuals (59%) |
| Arm/Group Title | Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venous Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cooling Cotton Pack - Diabetic Foot Ulcer |
|---|---|---|---|---|
| Arm/Group Description | A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. |
| Measure Participants | 26 | 29 | 12 | 16 |
| Worst pain |
0.85
|
0.4
|
0
|
-1.0
|
| Least pain |
0.3
|
0
|
-0.1
|
0
|
| Pain now |
0.4
|
0.14
|
0.1
|
-0.1
|
| Title | Differences in Step Counts |
|---|---|
| Description | Differences in step counts reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups. |
| Time Frame | Through study completion at 6 months from baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 140 participants were randomized, with a final completion for this outcome of 75 individuals (56%) |
| Arm/Group Title | Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venous Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cotton Cooling Pack - Diabetic Foot Ulcer |
|---|---|---|---|---|
| Arm/Group Description | A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. |
| Measure Participants | 23 | 23 | 15 | 14 |
| Mean (95% Confidence Interval) [Steps] |
17295
|
14234
|
13232
|
15479
|
| Title | Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire |
|---|---|
| Description | The Venous Insufficiency Epidemiological and Economic Study-Quality of life/Symptoms (VEINES QOL/Sym) Questionnaire was used to evaluate quality of life. A sum score is provided as an overall quality of life score for both the QOL and Sym portions of the questionnaire. This instrument was used only for the VLU groups because it is a disease-specific measure. Of the 26 items in the questionnaire, 25 items are combined to create a summary score (VEINES-QOL). One item which asks about the time of day the leg problem is most intense, question 2, provides only descriptive information and is not scored. A subset (symptoms score) of ten of these items, questions 1a to 1i and 7, is used to create a symptom score (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym scores, high values indicate better outcomes. VEINES-QOL scores can be compared only to other members of the same sample. Each set of VEINES-QOL scores will have a mean T-score = 50. |
| Time Frame | Through study completion at 6 months from baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to inadvertent scoring errors, there were data for 8 individuals. |
| Arm/Group Title | Cooling Gel Pack | Cooling Cotton Pack |
|---|---|---|
| Arm/Group Description | A cooling pack was applied to affected leg or foot skin where an ulcer has recently healed for 30 minutes three times a week (preventive maintenance). Patients self monitored skin temperature of affected skin daily 3 times per week to detect elevation and will cool the affected skin daily for 5 consecutive days (bolus) if the skin temperature becomes elevated 2°F above the baseline. | A cooling cotton pack was applied to affected leg or foot skin where an ulcer has recently healed for 30 minutes three times a week (preventive maintenance). Patients self monitored skin temperature of affected skin daily to detect elevation and will cool the affected skin daily for 5 consecutive days (bolus) if the skin temperature becomes elevated 2°F above the baseline. |
| Measure Participants | 6 | 2 |
| Quality of life |
13.8
|
-4.8
|
| Symptoms |
24.2
|
-4.3
|
| Title | Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory |
|---|---|
| Description | The Brief Pain Inventory (BPI) scale is reported as an average score. BPI rapidly assesses the severity of pain and its impact on functioning for intensity and Pain Intensity and Pain Interference. Pain Intensity is measured in four categories: worst, least, on average, and currently, while Pain Interference is measured in 7 categories: mood, work, general activity, walking, relationships, enjoyment of life, and sleep. The patient rates each of these on a scale from 0-10, 10 being excruciating pain intensity and a complete interference in their life. Subscores are determined by averaging over the 4 intensity items for the severity subscore and over the 7 interference items for the interference subscore; possible total scores range from 0 to 10. Higher scores indicate worse intensity and severity. |
| Time Frame | Through study completion at 6 months from baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 140 participants were randomized, with a final completion for this outcome of 83 individuals (59%) |
| Arm/Group Title | Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venous Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cotton Cooling Pack - Diabetic Foot Ulcer |
|---|---|---|---|---|
| Arm/Group Description | A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. |
| Measure Participants | 26 | 29 | 12 | 16 |
| Severity |
-0.5
|
-0.2
|
0
|
0.4
|
| Interference |
-0.4
|
-0.5
|
-0.1
|
0.1
|
| Title | Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire |
|---|---|
| Description | Change in metabolic equivalent of task (METS) min per week for physical activity per The International Physical Activity Questionnaire reported for 4 groups from baseline to 6 months end of study. Scoring HIGH indicate physical activity levels equate to ~1hour of activity per day or more at least moderate intensity level or engage in vigorous intensity activity on at least 3 days achieving a minimum total physical activity of at least 1500 MET min a week or 7 or more days of any combination of walking, moderate intensity or vigorous intensity activities achieving a minimum total physical activity of at least 3000 MET min a week. MODERATE suggests engagement equivalent to 30 min of at least moderate intensity activity on most days; engage in 3 or more days of vigorous intensity activity and/or walking of at least 30 min per day or 5 or more days of moderate intensity activity and/or walking of at least 30 minutes per day. LOW level means that neither MODERATE or HIGH levels are met. |
| Time Frame | Through study completion at 6 months from baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 140 participants were randomized, with a final completion for this outcome of 82 individuals (59%) |
| Arm/Group Title | Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venous Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cooling Cotton Pack - Diabetic Foot Ulcer |
|---|---|---|---|---|
| Arm/Group Description | A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. |
| Measure Participants | 25 | 29 | 12 | 16 |
| Mean (95% Confidence Interval) [minutes] |
73
|
799
|
1921
|
225
|
| Title | Time Spent in Minutes Engaging in Physical Activities |
|---|---|
| Description | Mean time spent in minutes engaging in physical activities, reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups. |
| Time Frame | Through study completion at 6 months from baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 140 participants were randomized, with a final completion for this outcome of 75 individuals (56%) |
| Arm/Group Title | Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venous Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cotton Cooling Pack - Diabetic Foot Ulcer |
|---|---|---|---|---|
| Arm/Group Description | A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. |
| Measure Participants | 23 | 23 | 15 | 14 |
| Mean (95% Confidence Interval) [Minutes] |
1420
|
2523
|
135
|
157
|
| Title | Participant Adherence to the Study Protocol |
|---|---|
| Description | Using study data logs, appropriate use of the thermometer and cooling pack was measured by the number of participants who adhered to the protocol for taking the temperature of the skin over the healed venous leg or diabetic foot ulcer. Adherence was defined as: the number of participants who were at least 80% adherent to taking their temperatures with the infrared thermometer each morning and the number of participants who were at least 80% adherent to performing the intervention every other day = 3 times times per week during the 6-month study period. |
| Time Frame | Daily measures starting at baseline for temperature and every other day cooling application during the 6-month study period. |
Outcome Measure Data
| Analysis Population Description |
|---|
| This outcome measured ALL participants in one group, rather than across arms, for adherence to temperature and use of cooling pack. |
| Arm/Group Title | Adherence |
|---|---|
| Arm/Group Description | All participants were assessed for adherence to the temperature and cooling protocols. |
| Measure Participants | 121 |
| Temperature |
106
252.4%
|
| Cooling |
82
195.2%
|
| Title | Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness |
|---|---|
| Description | Patients satisfaction was measured by study personnel a during end of study phone survey with the following questions asked as follows (Yes/No): Were study instructions adequate, was thermometer easy to use, found cooling helpful, would cool skin area if it was proven that cooling prevented reulceration; (Easy/Not Easy): completing logs, performing the cooling treatment. Data are for (Yes/No) as number of participants who reported "yes" or if (Easy/Not Easy) the number of participants who reported "easy." |
| Time Frame | Survey conducted at end of the 6-month study period. |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 140 participants were randomized, with a final completion for this outcome of 122 individuals (87%) |
| Arm/Group Title | Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venous Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cotton Cooling Pack - Diabetic Foot Ulcer |
|---|---|---|---|---|
| Arm/Group Description | A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. |
| Measure Participants | 36 | 34 | 27 | 25 |
| Study Instructions Adequate - Yes |
36
85.7%
|
34
85%
|
26
89.7%
|
25
86.2%
|
| Using Thermometer Easy - Yes |
36
85.7%
|
32
80%
|
27
93.1%
|
25
86.2%
|
| Completing Logs - Easy |
36
85.7%
|
33
82.5%
|
27
93.1%
|
25
86.2%
|
| Performing Cooling -Treatment - Easy |
35
83.3%
|
31
77.5%
|
26
89.7%
|
24
82.8%
|
| Cooling Helpful - Yes |
31
73.8%
|
21
52.5%
|
21
72.4%
|
18
62.1%
|
| Would Cool if Found to Prevent Re-Ulceration - Yes |
34
81%
|
33
82.5%
|
24
82.8%
|
25
86.2%
|
| Title | Knowledge Questionnaire of Study Instructions |
|---|---|
| Description | Participants were administered a 12-item (yes/no) questionnaire (test) during instruction at the start of the study, provided by the research personnel to determine comprehension of the protocol and to reinforce study procedures. Score of 12 or 100% was given for all items scoring correctly (1 point per item). Any items for which "no" was answered, remediation was conducted by study personnel at the time the questionnaire was conducted. Means scores are reported per VLU and DFU cooling pack intervention and VLU and DFU cotton cooling pack control. |
| Time Frame | Baseline after participant enrollment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of 140 participants, 140 (100%) completed the questionnaire. |
| Arm/Group Title | Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venus Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cotton Gel Pack - Diabetic Foot Ulcer |
|---|---|---|---|---|
| Arm/Group Description | A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. |
| Measure Participants | 42 | 40 | 29 | 29 |
| Mean (Full Range) [score on a scale] |
11.7
|
11.9
|
11.8
|
11.9
|
Adverse Events
| Time Frame | Data were collected for each participant for 6 months during study enrollment period. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ClinicalTrial.gov definitions were used and were consistent with reporting requirements for MUSC IRB | |||||||
| Arm/Group Title | Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venous Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cooling Cotton Pack - Diabetic Foot Ulcer | ||||
| Arm/Group Description | A cooling pack was applied to affected leg skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed venous leg ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected leg skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed leg ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed venous leg ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling pack was applied to affected foot skin where an ulcer was recently healed for 30 minutes three times a week (preventive maintenance). Participants self monitored skin temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling gel pack: Individuals self monitored temperature of skin over a recently healed diabetic foot ulcer with a dermal thermometer. A cooling gel pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | A cooling cotton pack was applied to affected foot skin where an ulcer was recently healed, for 30 minutes three times a week (preventive maintenance). Patients self monitored temperature of affected skin daily to detect elevation and cooled the affected skin daily for 5 consecutive days (bolus) if the skin temperature became elevated 2°F above the baseline. Cooling cotton pack: Individuals self monitored skin temperature of skin over a recently healed foot ulcer with a dermal thermometer. A cotton filled pack was applied to skin of recently healed diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increased and stayed elevated 2°F above the usual temperature of that site, the individual cooled the skin 5 consecutive days and continued to monitor skin temperature. | ||||
All Cause Mortality |
||||||||
| Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venous Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cooling Cotton Pack - Diabetic Foot Ulcer | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/42 (2.4%) | 0/40 (0%) | 0/29 (0%) | 0/29 (0%) | ||||
Serious Adverse Events |
||||||||
| Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venous Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cooling Cotton Pack - Diabetic Foot Ulcer | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/42 (9.5%) | 2/40 (5%) | 3/29 (10.3%) | 4/29 (13.8%) | ||||
| Cardiac disorders | ||||||||
| Heart attack or failure | 2/42 (4.8%) | 2 | 0/40 (0%) | 0 | 1/29 (3.4%) | 1 | 0/29 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||
| Fainted | 0/42 (0%) | 0 | 0/40 (0%) | 0 | 0/29 (0%) | 0 | 1/29 (3.4%) | 1 |
| Infections and infestations | ||||||||
| Infection | 0/42 (0%) | 0 | 1/40 (2.5%) | 1 | 0/29 (0%) | 0 | 1/29 (3.4%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Renal cancer | 0/42 (0%) | 0 | 1/40 (2.5%) | 1 | 0/29 (0%) | 0 | 0/29 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Shortness of breath | 2/42 (4.8%) | 2 | 0/40 (0%) | 0 | 1/29 (3.4%) | 1 | 0/29 (0%) | 0 |
| Vascular disorders | ||||||||
| Stroke | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 | 1/29 (3.4%) | 1 | 0/29 (0%) | 0 |
| Amputation | 0/42 (0%) | 0 | 0/40 (0%) | 0 | 0/29 (0%) | 0 | 2/29 (6.9%) | 2 |
Other (Not Including Serious) Adverse Events |
||||||||
| Cooling Gel Pack - Venous Leg Ulcer | Cooling Cotton Pack - Venous Leg Ulcer | Cooling Gel Pack - Diabetic Foot Ulcer | Cooling Cotton Pack - Diabetic Foot Ulcer | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/42 (33.3%) | 7/40 (17.5%) | 15/29 (51.7%) | 10/29 (34.5%) | ||||
| Infections and infestations | ||||||||
| Infection | 0/42 (0%) | 0 | 0/40 (0%) | 0 | 1/29 (3.4%) | 1 | 0/29 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Injury | 2/42 (4.8%) | 2 | 1/40 (2.5%) | 1 | 0/29 (0%) | 0 | 2/29 (6.9%) | 2 |
| Skin and subcutaneous tissue disorders | ||||||||
| New ulcers | 10/42 (23.8%) | 10 | 5/40 (12.5%) | 5 | 3/29 (10.3%) | 3 | 4/29 (13.8%) | 4 |
| Recurrent ulcers | 6/42 (14.3%) | 6 | 3/40 (7.5%) | 3 | 11/29 (37.9%) | 11 | 5/29 (17.2%) | 5 |
| Rash | 1/42 (2.4%) | 1 | 0/40 (0%) | 0 | 0/29 (0%) | 0 | 0/29 (0%) | 0 |
| Surgical and medical procedures | ||||||||
| Surgery | 0/42 (0%) | 0 | 0/40 (0%) | 0 | 3/29 (10.3%) | 3 | 2/29 (6.9%) | 2 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Teresa J. Kelechi |
|---|---|
| Organization | Medical University of South Carolina |
| Phone | 843-792-4602 |
| kelechtj@musc.edu |
Responsible Party:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT02626156
Other Study ID Numbers:
- Pro00043450
First Posted:
Dec 10, 2015
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021